More than 30 million people have been vaccinated against influenza A in Europe.

After other cases in Europe, three children and three adults have developed this rare chronic sleeping disorder after being vaccinated in France. The link between the two events is not yet established.

Six cases of narcolepsy with cataplexy – a rare disorder characterized by chronic sleepiness, together with a loss of muscle tone – have been detected in France in persons vaccinated against influenza A/H1N1. These cases, identified since August 23, have been reported to Afssaps. The people – three children and three adults – had been vaccinated either with Pandemrix vaccine ® (5 cases), or Panenza ® (one case). However, for the moment a link between vaccination against influenza A/H1N1 and the onset of narcolepsy has not been established.

On 18th August 2010, Sweden had informed the European Medicines Agency (EMA) and all member states of the European Union of the occurrence of six cases of narcolepsy in children aged 12-16 years, one or two months after vaccination with Pandemrix ®. This vaccine, which had been granted authorization to market in May 2008, was used in France in the recent campaign of vaccination against the H1N1 influenza pandemic. Three other pandemic vaccines were used during this campaign: @ Panenza non-adjuvanted vaccine and Focetria @ and Celvapan @.

Any adverse reactions should be reported

Since the information distributed by the Swedish Agency, cases of narcolepsy have been reported in Finland and France. To date, a total of 22 cases of narcolepsy have been reported in Europe after vaccination. Afssaps said that any serious and / or unexpected adverse events must be reported by health professionals to regional centers of pharmacovigilance (CRPV).